The WARFARIN (Warfarin Adverse Event Reduction for Adults Receiving Genetic Testing at Therapy Initiation) study, designed to demonstrate the value of genetic testing for guiding warfarin dosing, has received the thumbs-up from CMS and is a major step forward for future reimbursement decisions.
(The randomized, blinded, parallel-group study was designed and funded by the privately held Iverson Genetic Diagnostics, Inc., which sells a test that can be used to predict response to the generic injectable anticoagulant warfarin and help guide dosing.)
The trial design was authorized by Centers for Medicare and Medicaid Services under its coverage with evidence development program. The agency decided in 2009 that Medicare would not cover the genetic testing for routine use, but it would for randomized controlled trials. In issuing the decision, CMS made clear that it wanted to see prospective results examining use of the tests.
The 18-month WARFARIN study will include 7,000 patients over the age of 65 and assess the practical value of testing for these genetic mutations, based on rates of severe hemorrhage and thromboembolic adverse events. Per request by CMS, the study will be monitored by an independent data coordinating facility.
Via molecular diagnostics specifically called out in the amended FDA label, the health benefits and the resulting savings in health care costs generated by using personalized warfarin dosing decisions are estimated to prevent 85,000 serious bleeding events and 17,000 strokes annually – and that’s just in the United States. And estimates predict the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually. And that’s the mid-range.
“Safety means doing the right things for patients.”
Janet Woodcock
